System and Method For Detecting Atrial Activity Signal Using A Monobody Lead In A Single Chamber Implantable Cardioverter/Defibrillator

ABSTRACT

A single-chamber implantable device for detecting a patient&#39;s atrial activity using a monobody lead is disclosed. The monobody lead ( 10 ) includes a ventricular coil ( 16 ), a supraventricular coil ( 18 ), a distal electrode ( 14 ) forming three electrodes for detecting depolarization signals. A generator ( 12 ) of the implantable device collects a first unipolar signal ( 20 ) between the ventricular coil and the generator housing and a second unipolar signal ( 22 ) between the supraventricular coil and the generator housing. An independent component analysis is performed to the detected depolarization signals to determine an estimated atrial activity signal from the first and second unipolar signals.

The present application claims the benefit of French Application No.09-58898 entitled “Single Chamber Implantable Cardioverter/DefibrillatorWith Detection Of The Atrial Activity By A Monobody Lead” and filed Dec.11, 2009, which is hereby incorporated by reference in its entirety.

FIELD

The present invention relates to “active implantable medical devices” asdefined by the 20 Jun. 1990 Directive 90/385/EEC of the Council of theEuropean Communities, and more particularly to devices that respond to atachyarrhythmia and deliver to the heart of a patient electrical pulsesof a high energy level that significantly exceeds the energy levelrequired for a simple cardiac stimulation.

BACKGROUND

The devices that deliver high energy electrical pulses are generallycalled implantable cardioverter/defibrillators, or ICDs. They generallyhave two principal elements, a pulse generator, and a lead or a systemof leads. The pulse generator (often more simply referred to as a“generator”) functions to monitor the patient's cardiac activity andgenerate high energy electrical pulses when the heart is determined tohave a ventricular arrhythmia that may be treated by applying a shock.As defined herein, the term “shock” or “shock energy” should beunderstood to mean an electrical pulse of a high energy that issignificantly stronger than the electrical energy used for applyingconventional stimulations. Such high energy electrical pulse includes ashock for cardioversion and/or defibrillation. The lead or system ofleads is connected to the generator and functions to appropriatelydistribute the shock energy to the patient's heart. EP 0773039 A1 andits counterpart U.S. Pat. No. 5,776,165 assigned to Sorin CRM(previously known as ELA Medical) describes an exemplary generator/leadsystem, and a technique for selecting an application-specific optimalconfiguration for delivering required shock energy.

Typically, shock energy is delivered only when it is determined that atrue ventricular tachycardia (VT) exists, and not when asupra-ventricular tachycardia (SVT) exists. In the latter case, the SVTis of an atrial origin, and the shock electrode is located at theventricle, therefore this way of shock energy delivery would beinefficient because the shock energy would be delivered to theventricle, not to the atrial region. In addition, the application of ashock in a conscious patient is extremely painful and agonizing, becausethe delivered energy is well above the typical pain threshold.Furthermore, the application of a shock causes side effects on the heartrhythm as it increases a risk of developing secondary disorders, on thefunctional integrity of the patient's myocardium, and generally, on thepatient's physiological balance.

It is therefore desirable to deliver high energy shocks only whenappropriate and only if a less painful alternative therapy, such as anappropriate stimulation of the atrium, is not possible.

An analysis of the atrial activity, which implies in particular therecognition of P waves, is a fundamental basis of this technical field.A dual-chamber defibrillator includes circuits for detecting atrialheart rhythm, from which a situation of atrial fibrillation, such as anSVT, is easily detected so as to inhibit the delivery of a shock therapyto the ventricle. However, a single-chamber defibrillator does not havesuch circuits for detecting rapid activity of the atrium. Thus, if theventricular rate is fast enough, the device may unavoidably deliver anunintended and inappropriate shock to the ventricle.

However, it is recognized that implementation of a single-chamberdefibrillator is sufficient for patients in many cases, especially forthose patients for whom a defibrillator is indicated for therapeutictreatment, but whose sinus node has no dysfunction. It should be notedthat although implantation of a dual chamber defibrillator isadvantageous in improving performance with regard to the classificationof tachyarrhythmias (i.e., VF and SVT discrimination), it also isdisadvantageous because it increases the risk of complicationsassociated with the relatively greater number of leads and electrodes.

Implantable devices having leads to collect an atrial detection signalusing a defibrillation lead are known. For example, U.S. Pat. No.4,643,201 (assigned to Medtronic), U.S. Pat. No. 5,628,779 (assigned toPacesetter Inc.) and U.S. Pat. No. 6,321,122 (assigned to CardiacPacemakers Inc.) describe various types of leads including a branch or abend with a specific electrode that is positioned at or in the vicinityof the atrium, once the lead is implanted. EP 0801960 A2 describesanother specific type of lead, with a component floating in the atrium,a bipolar electrode pair, a distal component into the ventricle and adistal electrode.

These known implantable devices, however, have relatively complex andspecific leads that are not adequate for general use. On the other hand,these leads and electrodes located at the atrium float electricallydelivering a relatively noisy atrial detection signal, thus making ananalysis of any atrial rhythm difficult.

It is known in the art to connect a generator to a “monobody” lead,which is a single lead that contains various electrodes both to monitorthe patient's heart activity and to deliver shock energy. An issue thatarises with such a monobody lead is that the collection (also called thedetection) of a signal representative of atrial activity is difficultbecause of signals for noise, e.g., muscular activity and ventricularactivity that are also collected and mask the atrial activity component.

EP 1118349 A1 and its counterpart U.S. Pat. No. 6,636,770, assigned toSorin CRM (previously known as ELA Medical), describes a monobody lead,without any ramification or bent, equipped in its proximal region withtwo atrial electrodes, two ventricular electrodes, and asupraventricular electrode for the delivery of a shock energy. Theatrial signal is collected, on one embodiment, between thesupraventricular electrode and the atrial electrode connected to it,and, on the other embodiment, between the supraventricular electrode anda second atrial electrode that is not connected to the supraventricularelectrode. Even if the signal quality is improved with this leadstructure, this lead structure is a non-standard model, therefore itcannot be implemented easily and widely by conventional techniques.

Other techniques have been proposed to collect atrial activity withmonobody standard leads including one (or two) distal electrode(s) formonopolar detection (or bipolar detection, respectively) of aventricular signal, a ventricular coil forming a defibrillationelectrode, and a coil positioned mainly in the superior vena cava (SVC),in the vicinity of the atrium. The difficulty with this technique isthat the SVC coil is not an electrode suitable for atrial detection, andit does not allow for a proper collection of atrial cardiac activitysignal, especially because this electrode is electrically floating anddelivering a highly noisy signal.

In particular, the atrial signal collected on the SVC coil (or moreprecisely, a monopolar detection between the SVC coil and the generatorhousing) is distorted by interference from the ventricular signal, whichis often greater in amplitude than the atrial signal.

Techniques have been proposed to discriminate the atrial and ventricularcomponents and to extract the atrial signal having a lower amplitudethan the ventricular signal.

U.S. Pat. No. 5,776,072 describes one proposal in which, after signaldetection and appropriate filtering, a transfer function of theventricular channel signal compared to the signal on the combinedchannel (atrial+ventricular) is estimated. The estimated transferfunction reflects the contribution of the R-wave to the signal on thecombined channel. The application of the estimated transfer function tothe signal of the combined channel provides a resultant signal that issubtracted from the signal collected on the combined channel to obtain aresidual signal corresponding to an approximation of the P wave.

U.S. Pat. No. 5,885,221 (assigned to Cardiac Pacemakers Inc.) is anotherproposal that describes a technique, after estimating the transferfunction, for calculating a convolution between the combined signal andthe transfer function, thereby to obtain the contribution of theventricular signal. This ventricular signal contribution is then removedfrom the combined signal to deliver an estimate of the atrial signal.

In these two prior art techniques, the discrimination between atrial andventricular components is obtained by identifying and subtracting theR-wave signal component from a combined signal measured by a bipolardetection between the right ventricular (RV) coil electrode and the SVCcoil. The calculation performed is relatively complex, and the resultsof these techniques have never been published. Therefore, it is unknownwhether, in practice, these techniques produce a satisfactory estimateof the P wave, and whether they are clinically effective.

SUMMARY AND OBJECTS

It is therefore, an object of the present invention to collect andextract an atrial cardiac activity signal using a single-chamberdefibrillator equipped with a single ventricular lead, including astandard monobody lead.

Another object of the present invention is to provide a technique foranalyzing signals delivered by a conventional monobody defibrillationlead such as “double coil” (RV coil and SVC coil) standard monobodyleads, and without an atrial electrode for collecting a local atrialsignal.

Yet another object of the present invention is to use a “single-chamber”implantable cardioverter/defibrillator to effectively perform a “doublechamber” detection from signals measured with a conventional monobodylead and detect an atrial activity signal that is sufficient forclassification of tachyarrhythmias.

Broadly, the present invention is directed to collecting two unipolarsignals, a first signal measured between the RV coil and the housing,and a second signal measured between the SVC coil and this housing. AnIndependent Component Analysis (ICA) is performed on the first andsecond signals to discriminate two statistically independent signals,namely an atrial activity signal and a ventricular activity signal.

One preferred embodiment of the invention is a system including animplantable device that is of a single-chamberdefibrillator/cardioverter type, including a monobody lead and animplantable generator. The body of the monobody lead preferablyincludes: 1) a ventricular (RV) coil disposed on the patient's body andpositioned in the ventricle once the lead is implanted, forming a firstshock electrode for delivering a shock therapy and a first detectionelectrode for detecting cardiac activity (e.g., depolarization) signals;2) a supraventricular (SVC) coil disposed on the patient's body andpositioned in the superior vena cava when the lead is implanted, forminga second shock electrode for delivering a shock therapy and a seconddetection electrode for detecting cardiac activity (e.g.,depolarization) signals, and 3) a distal electrode, preferablypositioned in the ventricle when the lead is implanted, forming a thirddetection electrode for detecting cardiac activity (e.g.,depolarization) signals.

The implantable generator preferably includes: a housing made at leastin part of metal forming a reference potential electrode; circuits foranalyzing signals collected by the various cardiac activity detectionelectrodes, including an estimator means for estimating an atrialactivity signal; and circuits for delivering antitachycardia therapiesincluding shocks.

In one embodiment, the estimator means for estimating an atrial activitysignal comprises means for collecting a first unipolar signal between aventricular (RV) coil and the generator housing; means for collecting asecond unipolar signal between the supraventricular (SVC) coil and thegenerator housing; and means for performing an ICA analysis on the firstand second unipolar signals, and determining therefrom an estimatedatrial signal.

Preferably, the implantable device includes means for transforming theestimated atrial signal, after performing the ICA analysis, means fortransforming said estimated atrial activity signal by a derivativeoperation to obtain an estimated atrial signal, means for normalizingthe estimated atrial signal to a predetermined maximum absolute value,and means for applying a predetermined gain to the estimated atrialsignal after normalization. It should be understood that thenormalization step may be performed on the estimated atrial signal or onthe transformed estimated atrial signal, as deemed appropriate.

The means for performing an ICA analysis may operate on a matrix ofmixed data having a set of matrix coefficients. The matrix coefficientsmay be determined by a practitioner, an external device, and/or by theimplantable device. More preferably, the matrix coefficients arepreviously determined and stored in a memory of the implantable device.It is understood that the matrix coefficients can be updated in thememory of the implantable device by an external programmer as apractitioner determines a change in the patient's clinical status.

In another embodiment, a plurality of given matrices of mixed data maybe provided, along with means for selecting one of the plurality ofgiven matrices to be applied in accordance with at least one criterionrelated to the patient's status. The criterion may be related to thepatient's position, for example, determined by a sensor responsive tothe patient's relative position to the analysis circuits of theimplantable device.

In yet another embodiment, the implantable device includes means foranalyzing a cardiac rhythm to classify tachyarrhythmias from theestimated atrial signals and a ventricular activity signal collected bythe electrodes of the implantable device, and/or means for transmittingthe estimated atrial activity signal to an external programmer. Theexternal programmer preferably displays the estimated atrial activitysignal on a display screen suitable for a practitioner to diagnose.

Advantageously, the use of a simple, standard medical device such as aknown generator structure and a conventional monobody lead providesseveral benefits: minimum cost, fast and simple implantation procedure,minimizing the risk caused by implanting multiple leads.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features, characteristics and advantages of the presentinvention will become apparent to a person of ordinary skill in the artfrom the following detailed description of preferred embodiments of thepresent invention, made with reference to the drawings annexed, in whichlike reference characters refer to like elements and in which:

FIG. 1 is a schematic view of a single-chamber defibrillator implantedin a patient, with a dual coil monobody lead, in accordance with apreferred embodiment of the present invention;

FIG. 2 shows representative examples of timing diagrams of the signalscollected by the devices of FIG. 1, and of signals processed inaccordance with present invention; and

FIG. 3 is a flow chart illustrating a process for implementing thepresent invention.

DETAILED DESCRIPTION

With reference to FIGS. 1-3, various embodiments of the device andprocess according to the present invention will now be described.

In regards to its software aspects, the present technique for detectingatrial activity signal using a monobody lead can be implemented by anappropriate programming of a controlling software of a known device, forexample, a cardiac pacemaker or a defibrillator/cardioverter, includinghardware circuits and a control logic for collecting signals provided byendocardial leads and/or one or more implanted sensors. The presentinvention may particularly be applied to implantable devices such asthose of the Ovatio or Paradym device families produced and marketed bySorin CRM, Clamart France, formerly known as ELA Medical, Montrouge,France (Sorin Group).

A suitably implantable device such as those mentioned above includes aprogrammable microcontroller having a microprocessor to receive, format,and process electrical signals collected (detected) by implantedelectrodes and to generate and deliver stimulation pulses to theseelectrodes. It is possible to transmit by telemetry software and storeit in a memory of an implantable device, and execute the software toimplement the functions and features of the present invention describedherein. The adaptation of these implantable devices to implement thefunctions and features of the present invention is believed to be withinthe abilities of a person of ordinary skill in the art, and thereforewill not be described in detail.

In FIG. 1, reference 10 designates a monobody lead, having a distal endthat is inserted into a patient's venous network in both atrial andventricular cavities to detect the cardiac activity and apply asrequired a shock. The lead 10 is provided at its proximal end withvarious connection elements to couple it to a generator 12, such as animplantable cardioverter/defibrillator, such as Paradym and Ovatio branddevices of Sorin CRM.

The lead 10 carries a distal electrode 14 for both detection andstimulation positioned at the apex of a right ventricular cavity. Thelead 10 also includes on its the distal end a first shock electrode coil16 (hereinafter referred to as “RV” coil) placed in a right ventricleand forming, for example, a negative terminal for applying a shock fordefibrillation, e.g., to a ventricle, more preferably to the rightventricle. The lead 10 also carries a second shock electrode coil 18(hereinafter referred to as “SVC” coil) placed in the superior vena cavafor applying a shock to the atrium.

One suitable monobody lead is, for example, the Isoline modelmanufactured by Sorin CRM, whose detailed structure is described in EP1557194 A1 and its counterpart U.S. Patent Publication 2005/0177219,assigned to Sorin CRM, the disclosure of which is hereby incorporated byreference in its entirety. The present invention advantageously usessuch a standard monobody lead to obtain a signal representative of theatrial activity (e.g., P waves), and an efficient discrimination oftachyarrhythmias by its origin, atrial or ventricular.

The SVC coil 18, located at or near the right atrium collects the atrialactivity signal by monopolar detection between the SVC coil 18 and themetal housing (also referred to as a “case”) of the generator 12.

The collected signal also includes the ventricular signal that is oftenof a larger amplitude than the atrial signal. The present inventionoperates to eliminate the ventricular contribution as much as possible,by performing an independent component analysis between the unipolarsignal RV coil/housing (schematically shown in 20) and the monopolarsignal SVC coil/housing (schematically shown in 22).

The independent component analysis (ICA) is a method of data analysisthat operates a blind separation of signals from statisticallyindependent sources. The ICA analysis is, for example, described in thebook authored by Aapo Hyvarinen, Juha Karhunen and Erkki Oja,Independent Component Analysis, John Wiley & Sons, 2001, New York, towhich reference is made for further details on its implementation.

The purpose of an ICA analysis is to identify a linear generative modelrepresented by:

x=As,

where x is a vector of observed signals, s is a vector of sourcesignals, and A is a matrix of mixing of the sources (also referred to asa “mixing matrix”). The ICA analysis assumes that each component of thevector s=(s₁, s₂ . . . s_(n)) is mutually independent. This assumptionis adequate in the case where the atrial activity signal is independentof the ventricular activity signal because their sources are indeedindependent, even if the collected signals contain both components.

The vector x is the vector of the observed first and second signals,i.e., SVC coil/housing signal 22 and RV coil/housing signal 20. Thesetwo signals are of the same nature (both monopolar signals), use thesame reference potential (the housing as ground potential), and havecomparable amplitudes (because of the substantially similar size of theelectrodes being used). This facilitates the separation of the sourcesbecause the morphology of the different waves remains the same. Thesetwo observed signals are illustrated in the timing diagrams a) and b) inFIG. 2.

Referring to FIG. 3, the two signals, SVC coil/housing signal 22 and RVcoil/housing signal 20 collected separately by the device (blocks 24 and26) are subjected to the independent component analysis (block 28). TheICA analysis provides two separate components, namely a “source V”signal corresponding to the ventricular activity (block 30) and a“source A” signal corresponding to the atrial activity (block 32).

At this point, only the atrial source signal is of interest for thefollowing steps. It is possible to directly collect a ventricular signalof good quality (block 36) via the distal electrode 14 located at theapex of the right ventricle.

The source signal corresponding to the atrial activity (i.e., source A),resulting from the ICA analysis, is shown on the timing diagram c) inFIG. 2.

Once the atrial source signal identified, it undergoes a transformationvia, for example, a derivative operation conducted in software todetermine a vector of differences between two successive sample pointsand to reconstruct P-waves that are more similar to the real P wavescollected in a bipolar signal.

The result after transformation is shown on the timing diagram d) ofFIG. 2. This transformation by the derivation operation also allows theatrial source signal not to be reduced or degraded by the variousfilters and pre-processing that are applied to signals collected by aconventional defibrillator.

In a preferred embodiment, to the extent that there is an uncertaintywith respect to the magnitude of the sources obtained by the ICAanalysis, the derivative signal may be normalized so that its maximumabsolute value is made equal to unity.

In addition, the implantable device may apply an adequate gain (i.e.,amplification) to the estimated signal thus derived and normalized sothat the detection of P waves is done with a sensitivity similar to thatof conventional dual-chamber devices, for example, a gain value of about20.

The technique in accordance with the foregoing embodiment of the presentinvention was tested with fifteen patients by collecting and analyzingsignals about twenty seconds long. It produced good results showing aclear improvement in the detection of P waves as compared to aconventional technique of atrial detection that does not process the SVCcoil/housing signal 22.

In one embodiment of the present invention, the atrial source signalcollected and processed as described above may be used in combinationwith the ventricular detection signal collected by the distal electrode14, to perform a rhythm analysis to enable a classification oftachyarrhythmias.

This tachyarrhythmia analysis is, for example, performed using thePARAD, PARAD+ or STABILITY+ algorithms described in EP 0 626 182 A1 andits counterpart U.S. Pat. No. 5,462,060, EP 0 838 235 A1 and itscounterpart U.S. Pat. No. 5,868,793, EP 0 813 888 A1 and its counterpartU.S. Pat. No. 5,891,170 and EP 1 208 873 A1 and its counterpart U.S.Pat. No. 6,889,080 (all in the name of Sorin CRM, previously known asELA Medical, Sorin Group), the disclosures of which are incorporatedherein by reference.

In one embodiment of the present invention, the atrial source signalcollected and processed according to the present invention is used as adiagnostic tool for a physician, for example, by displaying the derivedsignal on a display screen of an external programmer.

In an alternative embodiment, where, for example, the calculationsrequired by ICA analysis are too complex to be performed in real time bythe microcontroller of the generator 12, the coefficients of a mixingmatrix may be calculated during a preliminary learning phase, forexample, during a patient follow-up session, and stored in a memory inthe implantable device. In this way, the implantable device applies thepredetermined mixing matrix coefficients in real time.

In yet another embodiment, coefficients for several mixing matrices,corresponding to different situations, may be calculated. For example,matrix coefficients may be calculated for a patient being in twodifferent physical positions, such as in a lying down position and in astanding up position, each of which corresponds to different positionsof the SVC and RV coils in the myocardium, and leads to significantlydifferent morphology signals.

The implantable device in this embodiment selects the appropriate matrixcoefficients according to the situation appropriate at the time of theICA analysis. The position of the patient may be determined and used bythe implantable device to select an appropriate set of matrixcoefficients for the ICA analysis. The patient's position may bedetermined in any manner known. For example, the position of the patientcan be determined in a known manner by an analysis of the patient'scardiac electrogram. See, e.g., EP 278,864 (assigned to Sorin CRM),which describes such a position determination, which disclosure isincorporated herein by reference. Alternately, a sensor can be used,e.g., a three dimensional accelerometer, for determining the patient'sposition, as described in Igarashi, “Integrated Microsized SemiconductorStrain Gauge And Its Biomedical Applications,” Implantable sensors forclosed-loop prosthetic systems, Chapter 6, (Futura Publishing CompanyInc., 1985; edited by Wen H. Ko and co-edited by Jacques Mugica & AlainRipart).

One skilled in the art will appreciate that the present invention can bepracticed by other than the embodiments described above, which areprovided for purposes of illustration and not of limitation.

1. An active implantable medical device for estimating an atrialactivity signal representative of a patient's atrial depolarizationactivity, comprising: a monobody lead (10) comprising: a ventricularcoil (16) positioned in the ventricle of the patient when implanted,said ventricular coil being a first shock electrode and a firstelectrode for detecting depolarization signals; a supraventricular coil(18) positioned in the superior vena cava of the patient when implanted,said supraventricular coil being a second shock electrode and a secondelectrode for detecting the depolarization signals; and a distalelectrode (14) positioned in the ventricle of the patient whenimplanted, said distal electrode being a third electrode for detectingthe depolarization signals; and a generator (12) comprising: a housingforming a metal reference potential electrode; means for analyzing thedepolarization signals collected by said first, second and thirddetection electrodes, comprising an estimator means for estimating theatrial activity signal, and means for delivering an antitachycardiashock to the patient's ventricle, wherein said estimator means furthercomprises: means (24) for collecting a first unipolar signal (20)between the ventricular coil and the housing of the generator; means forcollecting a second unipolar signal (22) between the supraventricularcoil and the housing of the generator; and means (28) for performing anIndependent Component Analysis (ICA), and determining, from said firstand second unipolar signals, an estimated atrial activity signal.
 2. Thedevice of claim 1, further comprising means for normalizing saidestimated atrial activity signal to a predetermined maximum absolutevalue.
 3. The device of claim 1, further comprising means fortransforming said estimated atrial activity signal by a derivativeoperation.
 4. The device of claim 3, further comprising means fornormalizing said estimated atrial activity signal to a predeterminedmaximum absolute value.
 5. The device of claim 4, further comprisingmeans for applying a predetermined gain to said estimated atrialactivity signal after normalization.
 6. The device of claim 1, whereinthe means for performing an ICA further comprises means for operatingthe ICA from a given mixing matrix having a set of matrix coefficients,and wherein said means for analyzing the depolarization signals, furthercomprising a memory storing said set of matrix coefficients.
 7. Thedevice of claim 1, wherein the means for performing an ICA furthercomprises means for providing a plurality of given mixing matrices, andmeans for selecting one of the plurality of given mixing matrices to beapplied in accordance with at least one criterion of the patient'sstatus determined by said means for analyzing the depolarizationsignals.
 8. The device of claim 7, wherein said criterion for patient'sstatus is a position of the patient.
 9. The device of claim 8, furthercomprising a sensor having an output corresponding to the position ofthe patient.
 10. The device of claim 1, further comprising means foranalyzing a rhythm and classifying tachyarrhythmias from said estimatedatrial activity signal and from a ventricular activity signal collectedbetween the distal electrode and the housing of the generator.
 11. Thedevice of claim 1, further comprising means for transmitting saidestimated atrial activity signal to an external programmer having adisplay screen, where said estimated atrial activity signal is displayedon said display screen of the external programmer.